Application 206500
- Type
- NDA
- Sponsor
- TERSERA THERAPS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VARUBI | ROLAPITANT HYDROCHLORIDE | TABLET;ORAL | EQ 90MG BASE | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69656-101 | Varubi | rolapitant | GlaxoSmithLine LLC | NDA | Current |
| 69656-101 | Varubi | rolapitant | Tesaro, Inc. | NDA | Current |
| 70720-101 | Varubi | rolapitant | TerSera Therapeutics LLC | NDA | Current |
| 70720-101 | Varubi | rolapitant | TerSera Therapeutics LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 64362 | SUPPL | 2020-08-21 |
| 64324 | SUPPL | 2020-08-20 |
| 53698 | SUPPL | 2018-04-16 |
| 53686 | SUPPL | 2018-04-16 |
| 24518 | ORIG | 2015-10-09 |
| 23022 | ORIG | 2015-10-09 |
| 19723 | ORIG | 2015-09-02 |
| 10575 | ORIG | 2015-09-02 |